Prescribers should monitor for somnolence and cns depressant effects, but impairment can occur in the absence of symptoms, and may not be reliably detected by ordinary clinical exam i. Gilotrif is indicated for the firstline treatment of patients with metastatic nonsmall cell lung cancer nsclc whose tumors have nonresistant epidermal growth factor receptor egfr mutations as detected by. Full prescribing information 1 indications and usage desonate is indicated for the treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. This patient information has been approved by the u. Rasburicase trade names elitek in the us and fasturtec in europe is a medication that helps to clear uric acid from the blood. Elitek rasburicase for injection, for intravenous use initial u. A detailed overview of treatment and patient management with elitek. Highlights of prescribing information these highlights do not include all the information needed to use aptensio xr safely and effectively. We invest billions of research dollars to find medicines that can help improve lives.
Consider the benefits and risks of elitek and possible risks to the fetus when prescribing elitek. It is a recombinant version of urate oxidase, an enzyme that metabolizes uric acid to allantoin. Highlights of prescribing information cardiac dysfunction. Serious irreversible myocardial toxicity with delayed congestive.
See 17 for patient counseling information and medication. Each subunit is made up of a single 301 amino acid polypeptide chain with a molecular mass of about 34 kda. Full prescribing information 1 indications and usage dupixent is indicated for the following diseases. Today, merck has more than 50 prescription products in key therapeutic. Federal register electronic distribution of prescribing. Control of plasma uric acid in adults at risk for tumor lysis syndrome. Highlights of prescribing information these highlights do not include all the information needed to use orencia safely and effectively. These highlights do not include all the information needed to use fluzone. Highlights of prescribing information these highlights do not include all the information needed to use elitek safely and effectively. Elitek rasburicase for managing uric acid levels when.
Adriamycin must not be given by the intramuscular or subcutaneous route. Humulinru500insulin human injection,for subcutaneous use initial u. Highlights of prescribing information these highlights do not include all the information needed to use nesina safely and effectively. Patients should be instructed to use desonate for the minimum amount of time as necessary to achieve the desired results because of the potential for desonate to suppress the. For current full prescribing information, please visit lab. Aarp health insurance plans pdf download medicare replacement pdf download aarp life insurance pdf download medicare benefits pdf download medicare part b pdf download medicare guidelines for rasburicase.
You can also visit this products label may have been updated. Highlights of prescribing information these highlights do not include all the information needed to use zyban safely and effectively. Velcade bortezomib for injection, for subcutaneous or intravenous use initial u. Highlights of prescribing information before initiating. Careassist patient access specialists are available mondayfriday, 9am 8pm est at 18339302273, option 1. Canadian coordinating office for health technology assessment emerging drug list rasburicase and hyperuricemia in cancer patients 11. We comply with the honcode standard for trustworthy health information. Gilotrif is indicated for the firstline treatment of patients with metastatic nonsmall cell lung cancer. Orencia abatacept for injection, for intravenous use orencia abatacept injection, for subcutaneous use initial u. Elitek prescribing information pdf the official hcp site for elitek rasburicase for the initial management of see trial design, and important safety information, including boxed warning. Addressing fundamental health issues, sanofi us strives to make major therapeutic solutions available for patients.
Many of these, as well as other sanofi genzyme products, are. Highlights of prescribing information these highlights do not include all the information needed to use toujeo safely and effectively. See 17 for patient counseling information and fda approved patient labeling. This algorithm has been developed for md anderson using a multidisciplinary approach considering circumstances particular to md andersons specific patient population, services and structure, and clinical information.
This indication is approved under accelerated approval based on an increase in dystrophin in skeletal. An information sheet for pharmacies about how elitek is supplied. Elitek rasburicase for injection, for intravenous use. Elitek is a recombinant urateoxidase indicated for initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. Sanofi us medical information provides healthcare professionals with accurate, unbiased, and balanced evidencebased product information. Indications and usage fluad is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes a and type b contained in the vaccine. Injectafer ferric carboxymaltose injection, for intravenous use initial u. Full prescribing information 1 indications and usage jardiance is indicated. Highlights of prescribing information these highlights do not include all the information needed to use norvir safely and effectively. Elitek enzymatically degrades uric acid in blood samples left at room temperature. Highlights of prescribing information these highlights do not include all the information needed to use ventavis safely and effectively.
Previously untreated stage iiiiv chl adult patients with previously untreated stage iiiiv classical hodgkin lymphoma chl in combination with doxorubicin, vinblastine, and dacarbazine. Highlights of prescribing information visual disturbance. Exondys 51 is indicated for the treatment of duchenne muscular dystrophy dmd in patients who have a confirmed mutation of the dmd gene that is amenable to exon 51 skipping. Relistor methylnaltrexone bromide injection, solution. Highlights of prescribing information these highlights do not include all the information needed to use northera safely and effectively. Norvir ritonavir tablets, for oral use warnings and precautions norvir ritonavir oral solution the following have been observed in patients receiving norvir. Highlights of prescribing information these highlights do not include all the information needed to use prolia safely and effectively. Tepezza teprotumumabtrbw for injection, for intravenous use. Northera droxidopa capsules, for oral use initial u.
Elitek rasburicase is an extremely effective but ex pensive medicine that can quickly lower uric acid blood levels and prevent kidney damage in people with cancer. See full prescribing information dosage adjustment in renal or hepatic impairment by indication. Rasburicase is produced by a genetically modified saccharomyces cerevisiae strain. See full prescribing information for aptensio xr aptensio xr methylphenidate hydrochloride extendedrelease capsules, for oral use, cii initial u. Siliq fda prescribing information, side effects and uses. Highlights of prescribing information interstitial lung. These highlights do not include all the information needed to use flolan safely and effectively. Highlights of prescribing information coadministration with. The cdna coding for rasburicase was cloned from a strain of aspergillus flavus rasburicase is a tetrameric protein with identical subunits. Prolia denosumab injection, for subcutaneous use initial u. Highlights of prescribing information these highlights do not include all the information needed to use keytrudasafely and effectively. Rasburicase is a recombinant urate oxidase enzyme approved for use by the food and drug administration in patients who are at risk of developing tumor lysis syndrome or for the management of elevated uric acid levels.
Assay plasma samples within 4 hours of collection drug information pdf dosage and administration. This will cause the current variety in the collector of v, this various current is amplified by v and controls the be current in of v ib. Highlights of prescribing information these highlights. Please see full prescribing information, including boxed warning pdf. Bexsero is a vaccine indicated for active immunization to prevent invasive disease caused by. Our portfolio includes more than 25 specialized products aimed at providing innovative treatments for unmet medical needs worldwide. Alecensa alectinib capsules, for oral use initial u.
The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. The limited available data with elitek use in pregnant women are insufficient to inform a drugassociated risk of major birth defects, miscarriage, or adverse maternal fetal outcomes. If you have any questions or want more information about geodon, talk with your doctor or pharmacist. Hypolipidemic agents, or antihyperlipidemic agents, are a diverse group of pharmaceuticals that are used in the treatment of high levels of fats lipids, such as cholesterol, in the blood hyperlipidemia. The list below includes our products marketed in the united states. Elitek prescribing information pdf admin may 23, 2019 the official hcp site for elitek rasburicase for the initial management of see trial design, and important safety information, including boxed warning. Llchighlights of prescribing information these highlights do not include all the information needed to use elitek safely and effectively.
Highlights of prescribing information these highlights do not include all the information needed to use picato gel safely and effectively. See full prescribing information for fluzone highdose. Vumerity diroximel fumarate delayedrelease capsules, for oral use. Our core business is the discovery and development of prescription medicines for diseases and conditions that impact millions of people. Siliq is a prescription medicine used to treat adults with moderate to severe plaque psoriasis. Highlights of prescribing information these highlights do not include all the information needed to use alecensa safely and effectively. Elitek rasburicase powder for solution, for intravenous infusion. Highlights of prescribing information these highlights do not include all the information needed to use imlygicsafely and effectively. They are often used in gout therapy as urinary alkalizers to prevent crystallization of urates. By providing your information and information about your patient on the front of the benefits investigation and enrollment form, you are requesting the services described on this form. Flolan epoprostenol sodium for injection, for intravenous use. Highlights of prescribing information these highlights do not. Identify and provide information on independent support services for patients and caregivers.
Adcircatadalafil tablets for oral administration initial u. Toviaz is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge. Highlights of prescribing information hyperglycemia or. Fluzone highdose influenza vaccine suspension for intramuscular injection. The food and drug administration fda or the agency is proposing to amend its prescription drug and biological product labeling regulations to require electronic distribution of the prescribing information intended for health care professionals, which is currently distributed in paper form on or. Elitek can cause serious and fatal hypersensitivity reactions including anaphylaxis. Belsomra is a central nervous system cns depressant that can impair daytime wakefulness even when used as prescribed. Highlights of prescribing information an initial dose of 600. The information you provide will only be used by janssen biotech, inc. Highlights of prescribing information these highlights do not include all the information needed to use velcade safely and effectively. See full prescribing information for additional information on the administration and preparation of xenleta tablets and injection. Consider the benefits and risks of elitek and possible risks to the fetus when prescribing elitek to a pregnant woman.
Full prescribing information 1 indications and usage spinraza is indicated for the treatment of spinal muscular atrophy sma in pediatric and adult patients. See table 1 in the full prescribing information for the recommended dosage. Belsomra fda prescribing information, side effects and uses. These highlights do not include all the information needed to use elitek safely and effectively. Several strategies are available for the prevention and treatment of tumor lysis syndrome, with rasburicase being the most recent. Highlights of prescribing information these highlights do not include all the information needed to use xifaxan safely and effectively. There may be diodes in places you would think would. Tumor lysis syndrome tls in adult patients page 1 of 7 disclaimer. Highlights of prescribing information these highlights do not include all the information needed to use injectafer safely and effectively. Highlights of prescribing information these highlights do not include all the information needed to use sprycel safely and effectively. Severe local tissue necrosis will occur if there is extravasation during administration. Imlygictalimogene laherparepvec suspensionfor intralesionalinjection initial u.
Elitek is indicated for the initial management of plasma uric acid levels in pediatric and adult patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anticancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. Recombinant urate oxidase rasburicase is safe and effective in managing hyperuricemia in children and adults. Highlights of prescribing information these highlights do not include all the information needed to use bat safely and effectively. Adakveo crizanlizumabtmca injection, for intravenous use. Elitek rasburicase basics powered by lowers uric acid to stop kidney damage in cancer patients. Sanofi is a leader in the global pharmaceutical market, with an extensive line of prescription medicines. Highlights of prescribing information these highlights do not include all the information needed to use adcircasafely and effectively. Elitek fda prescribing information, side effects and uses.
See important safety including boxed warnings for more information. Highlights of prescribing information these highlights do not include all the information needed to use humulinru500safely and effectively. Urate oxidase is known to be present in many mammals but does not naturally occur in humans. Elitek rasburicase is a recombinant urateoxidase produced by a genetically modified saccharomyces cerevisiae strain. For current full prescribing information, please visit lab05834. Immediately and permanently discontinue elitek if a serious hypersensitivity reaction. Highlights of prescribing information dosage adjustment and.
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